The European Society of Anaesthesiology Clinical Trial Network has been initiated on 2010 at the request of the ESA Research Committee and approval by the ESA Board of Directors with the primary aim to provide an infrastructure for Institutions, clinicians and scientists allowing to work across borders to improve the care of patients in the field of Anaesthesiology, Intensive Care Medicine, Peri-Operative Medicine, Emergency Medicine and Pain Medicine. International networks all over the world have demonstrated the advantages of collaboration to address and answer clinically relevant research questions. Long-term collaborative relationships within research, education and clinical practice require dedicated resources and infrastructure enabling access to the entire clinical community. The aim of the ESA Clinical Trial Network (CTN) is to build such a collaborative network. Over the past 4 years, a group of highly dedicated physician-scientists across Europe have conducted studies. Already in 2011 the first observational clinical trials could be performed with more than 500 centres, who contributed to the great success of the EUSOS study and the PERISCOPE study. The following years, ESA CTN selected the first paediatric multicentre audit of clinical anaesthetic practice in Europe, APRICOT: more than 250 centres participated and recruiting over 30,000 children. Currently NECTARINE, EPiMAP Obstetrics, PROBESE, MET-REPAIR, COMMAS are actively recruiting while other studies are getting ready for publication.
2. Progressing with needs
Entrusted by hundreds of hospitals, academic, and government organisations worldwide, ESA CTN represents a powerful and rapidly growing alternative to study organisation and management for clinical research. As a non-profit organisation, ESA provides a unique efficient, flexible, and low-cost way of managing different types of clinical studies. The ESA CTN Network has a proven record in conducting big clinical studies. A community of more than 6,000 clinicians make sure that the CTN studies evolve rapidly. Data management and analysis is done in close collaboration with the steering committee of the trial and the ESA research unit in Brussels. It has become clear that the ESA Research CTN Group should not merely focus on supporting observational studies but also consider supporting interventional studies. Pharmaceutical industries with investigational study drugs or medical device in the field of Anaesthesia, Intensive Care Medicine, Peri-Operative Medicine, Emergency Medicine and Pain Medicine could also gain interest in collaborating with ESA CTN. ESA CTN Coordination & Management can be used effectively in diverse settings: The ESA CTN includes services related to clinical study coordination; study management and allows flexibility and customisation.
3. The ESA CTN is focusing on three highly interrelated actions:
- Support studies identifying relevant research questions related mainly to Anaesthesia, Intensive Care Medicine, Peri-Operative Medicine, Emergency Medicine or Pain Medicine, but also to other specialties (nutrition, respiratory diseases, transfusion, thrombosis, cardiology, etc.) when they are related to anaesthesiology
- Foster collaborations between ESA members of various countries as well as with other organisations to improve patient outcome and anaesthesia Intensive Car Medicine, Peri-Operative Medicine, Emergency Medicine or Pain Medicine practice.
- Enforce quality and Good clinical Practice in the study coordination support and data Management
4. The ESA CTN Commitments:
- ESA is a Non-Profit organisation: all benefits will support actual costs or be reinvested in Research Grants and educational activities. No benefits granted to ESA shareholder, etc.
- Each Study Steering Committee should be independent from the Industry
- The Study selection Process should be transparent
- The Centre selection Process should be transparent
- The Industry should be “ESA Partner”
- The Industry and ESA CTN roles and responsibilities should be transparent: A contract should clearly state that Industry role is Sponsor and ESA the ‘collaborator’ (insurance and liability)
- The deployment of ESA CTN as A-CRO will be progressive and adapt ESA Staff according to the rapid growing structure